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Comparison of the Effects of Hydromorphone and Nalbuphine Patient Controlled Analgesia in Postoperative Pain After Cesarean Section

H

Huazhong University of Science and Technology

Status

Invitation-only

Conditions

Postoperative Pain
Patiet Controlled Analgesia

Treatments

Other: Observational study without intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06716359
Acute postoperative pain

Details and patient eligibility

About

Cesarean section is an essential surgical procedure in obstetrics, which not only addresses dystocia and certain obstetric syndromes, ensuring the safety of the maternal participants, but also increases perinatal survival rates and can save the mother's life. However, the surgical trauma and uterine contractions resulting from cesarean delivery lead to severe pain, which can hinder the mother's postoperative recovery and negatively affect her mental health. Therefore, improving postoperative pain management and addressing issues such as depression and anxiety are crucial challenges in clinical practice today.

Patient-controlled intravenous analgesia (PCA) is widely used in postoperative pain management after cesarean section due to its ability to maintain the minimum effective drug concentration, minimal fluctuation in drug levels, ease of management, and no restriction on activity. However, research on the effects and adverse reactions of hydromorphone and nalbuphine for postoperative pain relief in cesarean section is limited.

In this study, the investigators aim to compare the effects of hydromorphone hydrochloride and nalbuphine in obstetric PCA and examine how various clinical factors influence pain outcomes and adverse reactions. Based on multivariate analysis, the investigators further aim to construct and validate a predictive model for poor analgesic outcomes. To develop more personalized strategies for postoperative pain management following cesarean section, more personalized guidance strategies for postoperative pain management following cesarean section.

Enrollment

240 estimated patients

Sex

Female

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age range from 20 to 50 years old;
  • ASA grades I to III;
  • Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;
  • Pregnant women who are willing to participate in this study and sign informed consent forms.

Exclusion criteria

  • Have a history of dementia, mental illness, or any central nervous system disorder;
  • Pregnant women who are addicted to alcohol and drugs;
  • Difficulty in follow-up or poor patient compliance;
  • Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;
  • Serious complications occur during delivery;
  • Unable to cooperate with the research for any reason.

Trial design

240 participants in 1 patient group

Cesarean section surgery
Description:
Observational study
Treatment:
Other: Observational study without intervention

Trial contacts and locations

1

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Central trial contact

Xianwei Zhang, Doctor

Data sourced from clinicaltrials.gov

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